Viewing Study NCT06610994


Ignite Creation Date: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2026-01-02 @ 8:33 PM
Study NCT ID: NCT06610994
Status: RECRUITING
Last Update Posted: 2025-03-11
First Post: 2024-05-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Acute Effect of Local Vibration in Stroke Patients
Sponsor: Kırıkkale University
Organization:

Study Overview

Official Title: Investigation of the Acute Effect of Local Vibration Application on Gait and Balance in Stroke Patients
Status: RECRUITING
Status Verified Date: 2024-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of the research is to examine the acute effect of local vibration application on gait and balance in stroke patients.
Detailed Description: The purpose of our study; To examine the acute effect of local vibration application on spatiotemporal parameters of gait and balance in stroke patients.

Many treatment approaches are applied to accelerate motor recovery in stroke rehabilitation. These treatment approaches include Neurodevelopmental Therapy (NGT) treatment approaches and electrotherapy, traditional exercise approaches, as well as new technologies such as robotic devices and virtual reality, which offer new opportunities to increase training intensity by providing a more independent training in the field of rehabilitation. Another treatment approach that has recently attracted attention in neurorehabilitation is local or whole body vibration application. Vibration is defined as "a mechanical stimulus characterized by oscillatory movements". When vibration is viewed biomechanically, it has 3 parameters. These parameters; It is defined as the amplitude that determines the oscillation range of the vibration in millimeters, the frequency that indicates the number of repetitions in one second, and the power given by the acceleration that occurs during vibration.

Vibration can be applied to humans in two basic ways. The first method is local vibration application, which can be applied directly to the muscle or tendon with a hand-held device. The second method, called whole body vibration, is applied on the platform by a vibration source. Vibration applications in physiotherapy are generally 0.1-10 mm amplitude, 10-120 Hz. It is used in frequency and duration from 5 seconds to 60 minutes for up to 72 weeks. In whole body vibration, the degree of acceleration created by the platform surface can create a force up to 17 times the acceleration of gravity.

Wanderley et al. In their study, they applied vibration with a frequency of 100 Hz and an amplitude of 2 mm under the sole of the foot to female patients aged 60 and over with balance problems in 12 sessions of 10-minute applications for 5 weeks. As a result, they reported that vibration stimulation applied to the plantar region had positive effects on postural control and balance in women aged 60 and over with balance problems. In another study, Soffia Naghdi et al. In their case report, they reported that applying 100 Hz frequency plantar vibration to the sole of the foot of a right hemiplegic patient for 5 minutes was effective in balance development. Local vibration, in addition to the general physiotherapy and rehabilitation program, can improve walking performance in patients secondary to chronic stroke. The authors hypothesize that this could possibly be due to mechanical vibration stimulating the brain and reorganizing it. Additionally, the results of another study support this study. It has been shown that after applying low-amplitude local vibration to the flexor carpi radialis muscle and the intrinsic hand muscles of healthy individuals, there is increased excitability in the primary motor cortex area of the stimulated muscle.

When we examined the literature, we could not find any studies investigating the effect of local vibration applications to the gastrocnemius on spatiotemporal parameters and balance of walking in individuals with stroke.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: